1.Individualized red-cell transfusion strategy for non-cardiac surgery in adults: a randomized controlled trial.
Ren LIAO ; Jin LIU ; Wei ZHANG ; Hong ZHENG ; Zhaoqiong ZHU ; Haorui SUN ; Zhangsheng YU ; Huiqun JIA ; Yanyuan SUN ; Li QIN ; Wenli YU ; Zhen LUO ; Yanqing CHEN ; Kexian ZHANG ; Lulu MA ; Hui YANG ; Hong WU ; Limin LIU ; Fang YUAN ; Hongwei XU ; Jianwen ZHANG ; Lei ZHANG ; Dexing LIU ; Han HUANG
Chinese Medical Journal 2023;136(23):2857-2866
BACKGROUND:
Red-cell transfusion is critical for surgery during the peri-operative period; however, the transfusion threshold remains controversial mainly owing to the diversity among patients. The patient's medical status should be evaluated before making a transfusion decision. Herein, we developed an individualized transfusion strategy using the West-China-Liu's Score based on the physiology of oxygen delivery/consumption balance and designed an open-label, multicenter, randomized clinical trial to verify whether it reduced red cell requirement as compared with that associated with restrictive and liberal strategies safely and effectively, providing valid evidence for peri-operative transfusion.
METHODS:
Patients aged >14 years undergoing elective non-cardiac surgery with estimated blood loss > 1000 mL or 20% blood volume and hemoglobin concentration <10 g/dL were randomly assigned to an individualized strategy, a restrictive strategy following China's guideline or a liberal strategy with a transfusion threshold of hemoglobin concentration <9.5 g/dL. We evaluated two primary outcomes: the proportion of patients who received red blood cells (superiority test) and a composite of in-hospital complications and all-cause mortality by day 30 (non-inferiority test).
RESULTS:
We enrolled 1182 patients: 379, 419, and 384 received individualized, restrictive, and liberal strategies, respectively. Approximately 30.6% (116/379) of patients in the individualized strategy received a red-cell transfusion, less than 62.5% (262/419) in the restrictive strategy (absolute risk difference, 31.92%; 97.5% confidence interval [CI]: 24.42-39.42%; odds ratio, 3.78%; 97.5% CI: 2.70-5.30%; P <0.001), and 89.8% (345/384) in the liberal strategy (absolute risk difference, 59.24%; 97.5% CI: 52.91-65.57%; odds ratio, 20.06; 97.5% CI: 12.74-31.57; P <0.001). No statistically significant differences were found in the composite of in-hospital complications and mortality by day 30 among the three strategies.
CONCLUSION:
The individualized red-cell transfusion strategy using the West-China-Liu's Score reduced red-cell transfusion without increasing in-hospital complications and mortality by day 30 when compared with restrictive and liberal strategies in elective non-cardiac surgeries.
TRIAL REGISTRATION
ClinicalTrials.gov, NCT01597232.
Humans
;
Adult
;
Postoperative Complications
;
Erythrocyte Transfusion/adverse effects*
;
Blood Transfusion
;
Hospitals
;
Hemoglobins/analysis*
Result Analysis
Print
Save
E-mail